Anti-thyroglobulin Antibody, Kit and Use Thereof

An immunoassay kit, comprising:

• a first reagent, which contains a thyroglobulin antigen;
• a second reagent, which contains at least one kind of antibody or antigen-binding fragment thereof that specifically binds to thyroglobulin, comprising:
• a heavy chain variable region comprising the following three CDRs:
• CDR-H1 having an amino acid sequence selected from SEQ ID NOs:
• 1, 7, 13, 19, 25, 31, and a variant thereof, CDR-H2 having an amino acid sequence selected from SEQ ID NOs:
• 2, 8, 14, 20, 26, 32, and a variant thereof, and CDR-H3 having an amino acid sequence selected from SEQ ID NOs:
• 3, 9, 15, 21, 27, 33, and a variant thereof;
• and
• a light chain variable region comprising the following three CDRs:
• CDR-L1 having an amino acid sequence selected from SEQ ID NOs:
• 4, 10, 16, 22, 28, 34, and a variant thereof, CDR-L2 having an amino acid sequence selected from SEQ ID NOs:
• 5, 11, 17, 23, 29, 35, and a variant thereof, and CDR-L3 having an amino acid sequence selected from SEQ ID NOs:
• 6, 12, 18, 24, 30, 36, and a variant thereof.

The immunoassay kit according to claim 12, wherein the thyroglobulin antibody is selected from the antibody or antigen-binding fragment thereof that binds to thyroglobulin comprising:

• a heavy chain variable region comprising the following three CDRs:
• CDR-1 having an amino acid sequence selected from SEQ ID NOs:
• 1, 7, 13, 19, 25, 31, and variants thereof, CDR-H2 having an amino acid sequence selected from SEQ ID NOs:
• 2, 8, 14, 20, 26, 32, and variants thereof, and CDR-H3 having an amino acid sequence selected from SEQ ID NOs:
• 3, 9, 15, 21, 27, 33, and variants thereof;
• and
• a light chain variable region comprising the following three CDRs:
• CDR-L1 having an amino acid sequence selected from SEQ ID NOs:
• 4, 10, 16, 22, 28, 34, and variants thereof, CDR-L2 having an amino acid sequence selected from SEQ ID NOs:
• 5, 11, 17, 23, 29, 35, and variants thereof, and CDR-L3 having an amino acid sequence selected from SEQ ID NOs:
• 6, 12, 18, 24, 30, 36, and variants thereof,
• wherein each variant contains an amino acid mutation as compared to the amino acid sequence from which it is derived, and the amino acid mutation is a substitution, deletion, or
• addition of one or more amino acids.

An antibody or antigen-binding fragment thereof that binds to thyroglobulin, wherein the antibody or antigen-binding fragment thereof is:

• produced based on a hybridoma cell line deposited with the All-Russian National Collection of Industrial Microorganisms (VKPM) having Accession Number H-223;
• produced based on a plasmid in Escherichia coli Rosetta™(DE3)pLysS hTG02 VH deposited with VKPM having Accession Number B-14843, and a plasmid in Escherichia coli Rosetta™(DE3)pLysS hTG02 VL deposited with VKPM having Accession Number B-14844;
• produced based on a plasmid in Escherichia coli Rosetta™(DE3)pLysS hTG03 VH deposited with VKPM having Accession Number B-14845, and a plasmid in Escherichia coli Rosetta™(DE3)pLysS hTG03 VL, deposited with VKPM having Accession Number B-14846;
• produced based on a plasmid in Escherichia coli Rosetta™(DE3)pLysS hTG04 VH deposited with VKPM having Accession Number B-14847, and a plasmid in Escherichia coli Rosetta™(DE3)pLysS hTG04 VL deposited with VKPM having Accession Number B-14848;
• produced based on a plasmid in Escherichia coli Rosetta™(DE3)pLysS hTG05 VH deposited with VKPM having Accession Number B-14849, and a plasmid in Escherichia coli Rosetta™(DE3)pLysS hTG05 VL deposited with VKPM having Accession Number 13-14850;
• and
• produced based on a plasmid in Escherichia co/i Rosetta™(DE3)pLysS hTG006 deposited with VKPM having Accession Number B-14851.